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The New Medical Device Regulation (MDR) and the End User: Supporting Usability Through Documentation

The medtech industry is undergoing significant change, from the introduction of the new MDR to the growth of home-based healthcare and the uncertainties of Brexit.

At some recent Irish medtech events, the major topics dominating conversation were:

Indeed, these topics are interrelated, given that the central aim of the MDR is to establish high standards of usability and avoid safety risks and hazards for end users.

Unfortunately, insufficient attention is being given to documentation in the current discussion, despite its central importance to the MDR and the experience of the end user. For end users, labelling and Instructions for Use (IFUs) are key to learning about using a medical device, and understanding its functions and limits. The quality of the documentation that users receive can often dictate whether their experience of using the device is a positive or negative one.

This post primarily focuses on documentation, examining the role it plays in optimising usability, enhancing user experience, and supporting MDR compliance.

Are You Preparing for the MDR?

By now, we’re probably all familiar with the term “MDR”. The MDR is new legislation from the European Commission that officially came into force on 26 May 2017.*

The medtech industry is currently in the implementation phase, or, as it is commonly described, a transition from the former Medical Device Directives (MDDs) to the MDR. Medtech companies are tasked with updating their documentation and processes by May 2020 – the point at which all companies must be fully compliant with the MDR.

Key aspects of the MDR include changes in device classifications, new requirements around clinical data and post-market surveillance, and the introduction of Unique Device Identifiers (UDIs). Many medtech organisations are currently in the process of investigating how the MDR affects their business, so that they can prepare an implementation plan. This is a challenge for enterprises of all sizes, but particularly for small medtech companies and start-ups with limited resources.

We recently attended the Medical Technology Ireland Expo and Conference 2017 and the MedTec Ireland 2017 Conference in Galway. Both conferences provided a valuable forum for delegates to share information about the MDR, discuss concerns, and provide advice on planning and logistics. Speakers from the Health Products Regulatory Authority (HPRA) outlined the extensive work that is being done to give clarity on the new regulation and ensure that the European member states share a common understanding of it. HPRA representatives advised medtech companies to analyse the new legislation in detail and, if they haven’t already begun, to start preparing for the MDR immediately.

User Documentation and the MDR

The introduction of the MDR brings more clarity in terms of medical device regulations and improvements in patient treatment and user safety and experience. The MDR focuses heavily on safeguarding the end user and ensuring that they are suitably well-informed about devices. Therefore, it is unsurprising that the regulation affords documentation (and, particularly, user documentation) a key role.

The MDR sets out the requirements regarding the information supplied by manufacturers to medical device users. Each device must be accompanied by information specifying all performance and safety information relevant to the user. Clear usage and disposal procedures must be provided for devices, and content must be tailored to the level of the target audience’s technical knowledge.

The regulation states:

The medium, format, content, legibility, and location of the label and instructions for use shall be appropriate to the particular device, its intended purpose and the technical knowledge, experience, education or training of the intended user(s). In particular, instructions for use shall be written in terms readily understood by the intended user and, where appropriate, supplemented with drawings and diagrams.

From a documentation perspective, the MDR holds distinct challenges for medtech companies:

  • The need to generate more documentation at every stage of product development, including the post-market stage
  • The requirement to produce clear content that is specifically oriented towards the end user for new and legacy devices, including labelling, IFUs, and summaries of safety and clinical performance to be made available on the EUDAMED online database

This central focus on the end user parallels the growing emphasis on usability that is evident throughout the medtech field.

Importance of the End User

The medtech industry is moving towards consensus on the centrality of the end user to product design and development. Medical devices need to be easy to use to succeed in a market where users wield increasing power. Whether end users are patients, home caregivers, or medical professionals, they expect medtech companies to offer more personalised products, easier procedures, and an enhanced user experience.

Satisfying these end users requires a multidisciplinary approach involving engineering, design, and marketing, among others. Currently, there is a move from a product to a service model for medical devices and greater end user involvement in every stage of product development. In future, therefore, medtech development will need to rely on a much broader range of inputs, together with extensive real-world data and usability feedback.

At the Medical Technology Ireland Expo and Conference 2017 and the MedTec Ireland 2017 Conference, speakers and delegates agreed that investment in user-centred development is vital for successful product development. However, they cautioned that this must not come at the cost of investment in supply chain and manufacturing, and process improvement initiatives. All of these elements form part of the usability chain, and have a role in producing a safe and effective product for end users. Greater usability will not be achieved at the cost of process improvement efforts, but rather through their implementation. Process improvement is another area where effective documentation can aid successful outcomes.

User-Centred Documentation Strategy

Documentation plays a crucial role in optimising users’ experience of a product. The prioritisation of the end user evident throughout the medtech industry underlines the importance of telling the story of products effectively for users in marketing material, and providing clear, user-centred documentation. User documentation is a vital part of the usability chain – a chain that extends across the product life cycle from initial Research and Development (R&D) through design and post-market surveillance activities.

Given the MDR implementation time frame, the need to create accessible, end-to-end documentation is an immediate reality for medtech companies. It is essential for companies to consider whether they have the available in-house skills and resources to achieve the required standards of user documentation. If not, their options are to:

  • Provide training to help enhance the writing skillset of employees tasked with documentation activities outside of their main role
  • Avail of the support of documentation experts in developing clear instructions and user-friendly content

End-To-End Documentation

To succeed in the new regulatory climate, and the increasingly user-led marketplace, medtech companies need to acknowledge the important role of documentation in the usability chain, and consider how the various types of documentation involved in product development can support business processes and optimise usability.

An end-to-end documentation strategy can support MDR compliance.

Overview of documentation requirements throughout the medtech product lifecycle.

Implementing a coherent, end-to-end documentation strategy will help companies to:

  • Meet their regulatory obligations
  • Support end user safety and satisfaction
  • Facilitate greater organisational efficiency and foster process improvement

In short, careful end-to-end documentation planning can support process refinement across the entire product life cycle, while promoting better user outcomes.

The essential first step is to recognise the central role of documentation in achieving MDR compliance, as well as process and usability excellence. But where do you go from there? We recommend carrying out an end-to-end audit of your organisation’s current documentation practices. You’ll gain a clear picture from this analysis, allowing you to identify gaps, weaknesses, and areas for improvement.

Do you have questions or concerns about how to develop a documentation strategy that supports MDR compliance? Our Business Development Manager, Emmet Kearney, is available to discuss your documentation challenges and strategies and what supports you may need.

* Regulation 2017/746 on In-Vitro Diagnostic Devices (the IVDR) was introduced with the MDR. The date for full application of the IVDR is May 2022. The IVDR shares the central focus of the MDR on usability, the provision of accessible information, and end user safety, so the main points covered in our discussion also apply to the IVDR.

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